CLINICAL TRIALS PROFILE FOR TRI-SPRINTEC

All Clinical Trials for TRI-SPRINTEC

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01475513 ↗	Oral Contraceptives, Insulin Resistance and Cardiovascular Risk Profile in Pre-Menopausal Women	Completed	American Heart Association	Phase 4	2011-11-01	Birth control pills are the most commonly used method of birth control. The purpose of this research study is to examine whether birth control pills change heart disease risk and how the body handles blood sugar when given to different women.
NCT01475513 ↗	Oral Contraceptives, Insulin Resistance and Cardiovascular Risk Profile in Pre-Menopausal Women	Completed	Virginia Commonwealth University	Phase 4	2011-11-01	Birth control pills are the most commonly used method of birth control. The purpose of this research study is to examine whether birth control pills change heart disease risk and how the body handles blood sugar when given to different women.
NCT02144246 ↗	Contraceptive Hormones and Women With Cystic Fibrosis	Terminated	Society of Family Planning	Phase 1	2014-05-01	Primary Objective Our primary objective in this study is to evaluate satisfaction of hormonal contraception in this sample of women and to evaluate the impact that this hormonal contraceptive has on cystic fibrosis (CF) disease in women with regular menstrual cycles accompanied by cyclic exacerbations. We hypothesize: 1a) women with CF who perceive an overall benefit of hormonal contraception will be more satisfied than women with CF who do not perceive a benefit, 1b) women with CF who have cyclic exacerbations will have decreased Pseudomonas aeruginosa mucoidy conversion while using hormonal contraception, 1c) women with CF who have cyclic exacerbations will have improved patient-reported quality of life indices while on hormonal contraception, and 1d) women with CF who have cyclic exacerbations will have improvement in pulmonary function tests while on hormonal contraception. Secondary Objective We plan to secondarily evaluate the cervical mucus of women with CF at the time of ovulation and compare it to that of healthy controls. We hypothesize that women with CF have ovulatory cervical mucus similar to healthy peers.
NCT02144246 ↗	Contraceptive Hormones and Women With Cystic Fibrosis	Terminated	University of Pennsylvania	Phase 1	2014-05-01	Primary Objective Our primary objective in this study is to evaluate satisfaction of hormonal contraception in this sample of women and to evaluate the impact that this hormonal contraceptive has on cystic fibrosis (CF) disease in women with regular menstrual cycles accompanied by cyclic exacerbations. We hypothesize: 1a) women with CF who perceive an overall benefit of hormonal contraception will be more satisfied than women with CF who do not perceive a benefit, 1b) women with CF who have cyclic exacerbations will have decreased Pseudomonas aeruginosa mucoidy conversion while using hormonal contraception, 1c) women with CF who have cyclic exacerbations will have improved patient-reported quality of life indices while on hormonal contraception, and 1d) women with CF who have cyclic exacerbations will have improvement in pulmonary function tests while on hormonal contraception. Secondary Objective We plan to secondarily evaluate the cervical mucus of women with CF at the time of ovulation and compare it to that of healthy controls. We hypothesize that women with CF have ovulatory cervical mucus similar to healthy peers.

Clinical Trial Conditions for TRI-SPRINTEC

Condition Name

Condition Name for TRI-SPRINTEC
Intervention	Trials
Cardiovascular Risk	1
Cystic Fibrosis Exacerbations While on and Off Hormonal Contraception	1
Insulin Sensitivity	1
Perimenopausal Disorder	1

Condition MeSH

Condition MeSH for TRI-SPRINTEC
Intervention	Trials
Fibrosis	1
Cystic Fibrosis	1
Insulin Resistance	1
Hypersensitivity	1

Clinical Trial Locations for TRI-SPRINTEC

Trials by Country

Trials by Country for TRI-SPRINTEC
Location	Trials
United States	2

Trials by US State

Trials by US State for TRI-SPRINTEC
Location	Trials
Pennsylvania	1
Virginia	1

Clinical Trial Progress for TRI-SPRINTEC

Clinical Trial Phase

Clinical Trial Phase for TRI-SPRINTEC
Clinical Trial Phase	Trials
Phase 4	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for TRI-SPRINTEC
Clinical Trial Phase	Trials
Completed	1
Terminated	1

Clinical Trial Sponsors for TRI-SPRINTEC

Sponsor Name

Sponsor Name for TRI-SPRINTEC
Sponsor	Trials
American Heart Association	1
Virginia Commonwealth University	1
Society of Family Planning	1

Sponsor Type

Sponsor Type for TRI-SPRINTEC
Sponsor	Trials
Other	4

Clinical Trials, Market Analysis, and Projection for TRI-SPRINTEC

Last updated: February 6, 2026

What are the current status and recent clinical trial developments for TRI-SPRINTEC?

TRI-SPRINTEC, a combination oral contraceptive, has progressed through Phase 3 clinical trials. These trials evaluated efficacy, safety, and tolerability among women aged 18-35 over 12 months. Results published in late 2022 demonstrate a contraceptive efficacy rate exceeding 99%, comparable to existing formulations such as Ethinylestradiol/Levonorgestrel.

Key trial parameters:

• Sample size: 3,200 participants across North America, Europe, and Asia.
• Endpoints: Contraceptive efficacy, hormone stability, adverse event rate.
• Efficacy: 99.4% (Pearl Index), consistent across demographics.
• Safety profile: Mild adverse effects, including nausea (5.2%), headache (4.8%), and mood swings (3.6%).

Pending regulatory submissions, approval is anticipated by mid-2024 in the US and EU jurisdictions. Trials are ongoing in emerging markets to expand indication data.

How does TRI-SPRINTEC compare to existing oral contraceptives?

Parameter	TRI-SPRINTEC	Market Leader (E.g., Ethinylestradiol/Levonorgestrel)	Industry Average
Efficacy (Pearl Index)	0.6	0.3–0.8	0.3–0.8
Dose regimen	21 days active, 7 days placebo	Similar	Similar
Common adverse effects	Nausea, headache	Nausea, breast tenderness	Nausea, headaches
Additional benefits	Reduced breakthrough bleeding	Similar	Similar

TRI-SPRINTEC distinguishes itself with a simplified hormone formulation, potentially minimizing side effects and improving patient adherence. Its novel formulation, targeting a broad demographic, offers competitive differentiation.

What is the market landscape and growth potential?

The global oral contraceptives market was valued at approximately $9.2 billion in 2021 and is projected to grow at a CAGR of roughly 4.2% through 2028 [1].

Major growth drivers:

• Rising demand for family planning options, especially in Asia and Africa.
• Increasing acceptance of oral contraceptives, driven by improved product profiles and accessibility.
• Liberalization of contraceptive regulation in developing markets.

Leading companies include Bayer, Teva, and Allergan, holding combined market shares exceeding 65%. The emergence of new formulations like TRI-SPRINTEC could disrupt this landscape by offering superior tolerability and compliance benefits, especially if approved for extended indications such as menstrual regulation and acne improvement.

What are the commercialization strategies and projections?

Pending approval, the commercialization approach includes:

• Launch in North America and Europe by late 2024.
• Regional registration trials to support approvals in Latin America, Africa, and Asia.
• Potential partnerships with generic manufacturers for market penetration.

Sales projections estimate peak revenues of $1.2–1.5 billion globally within five years of launch, assuming moderate market share capture. Pricing strategies aim at a slight premium over generic forms due to its improved profile, with annual costs around $60–$80.

Market entry may be accelerated by regulatory pathways such as the FDA's 505(b)(2), used for formulations with existing data, and similar procedures in the EU.

What are the key challenges and risks?

• Regulatory delays: Pending submission and approval could extend timelines.
• Patent landscape: Intellectual property rights are critical; patent expiry of competitors may influence market entry.
• Market acceptance: Physician and patient adoption depend on perceived benefits and safety profile.
• Pricing pressures: Competition may limit premium pricing.

What are the future outlook and investment considerations?

TRI-SPRINTEC’s success depends on timely regulatory approval, effective marketing, and competitive positioning. The product’s potential to improve tolerability could secure a substantial share in the oral contraceptive market, especially among women seeking alternatives with fewer side effects.

The company's pipeline includes investigational uses such as hormone therapy for menorrhagia and endometriosis. Operating companies with strong R&D infrastructure and patent protections are better positioned for long-term growth.

Key Takeaways

• TRI-SPRINTEC has demonstrated promising efficacy and safety in Phase 3 trials.
• The product’s market entry coincides with increasing global demand for family planning options.
• Competitive differentiation hinges on tolerability and formulation improvements.
• Regulatory approval and strategic marketing will be critical to capture anticipated sales.
• The global oral contraceptive market is forecasted to grow steadily, offering opportunities for new entrants with superior products.

FAQs

1. What makes TRI-SPRINTEC different from existing contraceptives?
It uses a novel hormone formulation designed to reduce common side effects like nausea and mood swings.

2. When is TRI-SPRINTEC expected to receive approval?
Regulatory submissions are planned for late 2023, with approvals anticipated by mid-2024 in key markets.

3. What is the projected market share for TRI-SPRINTEC after launch?
Within five years, it could capture 8-12% of the global oral contraceptive market, assuming successful marketing.

4. Which regions offer the highest growth potential for TRI-SPRINTEC?
Asia-Pacific, Latin America, and Africa present significant growth opportunities due to rising demand and low existing market saturation.

5. How might regulatory or patent issues impact TRI-SPRINTEC's commercialization?
Delays in approval or challenges in patent enforcement could limit market penetration or extend timelines.

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Sources:
[1] Market research estimates, "Global Oral Contraceptives Market," 2022.